Details for New Drug Application (NDA): 208630
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NDA 208630 describes GLEOLAN, which is a drug marketed by Nxdc and is included in one NDA. It is available from one supplier. Additional details are available on the GLEOLAN profile page.
The generic ingredient in GLEOLAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
The generic ingredient in GLEOLAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
Summary for 208630
| Tradename: | GLEOLAN |
| Applicant: | Nxdc |
| Ingredient: | aminolevulinic acid hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208630
| Mechanism of Action | Fluorescence Contrast Activity |
Medical Subject Heading (MeSH) Categories for 208630
Suppliers and Packaging for NDA: 208630
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLEOLAN | aminolevulinic acid hydrochloride | FOR SOLUTION;ORAL | 208630 | NDA | Medexus Pharma, Inc. | 59137-231 | 59137-231-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 1.5GM/VIAL | ||||
| Approval Date: | Jun 6, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 6, 2024 | ||||||||
| Regulatory Exclusivity Use: | OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY | ||||||||
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